Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEE H10 REVIVE SE 4.5MM OUS; EMBOLECTOMY CATHETER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SEE H10 REVIVE SE 4.5MM OUS; EMBOLECTOMY CATHETER Back to Search Results
Catalog Number FRS21452299
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Intracranial Hemorrhage (1891); No Code Available (3191)
Event Date 03/13/2016
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).The revive se product was not returned for investigation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.Concomitant med products: guiding catheter (9fr optimo) and micro catheter (3fr rebar) manufacturer name/ physical manufacturer: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)) phone: the name of the initial reporter is unknown.The manufacturer representative was provided as the initial reporter name.Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
 
Event Description
As reported via the revive se pms (b)(6) (patient (b)(6)), a (b)(6) female experienced asymptomatic intracranial hemorrhage (ph 2) at the occluded vascular site.On (b)(6) 2016 (11:00pm): the patient developed an acute phase cerebral infarction accompanying occlusion of the internal carotid artery left middle cerebral artery (m1).Next day ((b)(6) 2016), the patient was hospitalized (3:02am).Before the procedure, aspects-ct:1point, aspects-dwi:1point, nihss:21points, tici:0.There was moderately torturous at the occluded site and there was no stenosis at proximal portion from the occlusion.The vascular diameter of treated vessel, proximal portion:2.84mm, and distal portion and the length of the blocked site were unknown.The t-pa was not applicable.The puncture time was at 3:48 am.The guiding catheter (9fr optimo (insertion time at 4: 32 am), the micro catheter (3fr rebar (insertion time 4:32am), the thrombectomy device (solitaire) were also used in this procedure.The revive se thrombectomy device ((b)(4)) was deployed 5 times at the occluded site and acquired tcic: 0 (6:00am).The solitaire was deployed 2 times, there was no change in tcic value.The procedure was completed (7:45 am).The guiding system was removed.Immediately after the procedure, the asymptomatic intracranial hemorrhage (ph 2) developed at the occluded vascular site.The revive se was deployed 3 times and the procedure was completed.On (b)(6) 2016: aspects-dwi: 11 points, on (b)(6) 2016: aspects-ct: 1 point and on (b)(6) 2016: mrs: 5, nihss: 15 points.The patient has a medical history of cardiovascular disease.She is under treatment for atrial fibrillation and heart failure.There was no history of stroke.Before the procedure, mrs:3.The device will not be returned for investigation.
 
Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported via the (b)(6) study patient 409-06, a (b)(6) female with a history of cardiovascular disease, atrial fibrillation and heart failure experienced asymptomatic cerebral hemorrhage after use of the revive se (frs21452299/t10104).The patient presented on (b)(6) 2016 (11:00pm) with acute phase cerebral infarction accompanying occlusion of the internal carotid artery/left middle cerebral artery (m1), and was hospitalized on (b)(6) 2016 (3:02am).Before the procedure, mrs was 3, aspects-ct was 1point, aspects-dwi was 1point, nihss was 21 points and tici was 0.There was moderately tortuosity at the occluded site and no stenosis at proximal to the occlusion.The vascular diameter of the treated vessel proximal portion was 2.84mm, distal portion and the length of the blocked site were unknown.T-pa was not administered.The puncture time was at 3:48 am.A guiding catheter (9fr optimo), microcatheter (3fr rebar), and thrombectomy device (solitaire) were also used in this procedure.The revive se was deployed 5 times at the occluded site and tici 0 was obtained (6:00am).The solitaire was deployed 2 times with no change in tici value.The procedure was completed (7:45 am).Immediately after the procedure, the asymptomatic intracranial hemorrhage (ph 2) developed at the occluded vascular site.The revive se was deployed 3 times and the procedure was completed.On (b)(6) 2016, aspects-dwi was 11 points and on (b)(6) 2016, aspects-ct was 1 point.On (b)(6) 2016, mrs: 5 and nihss was 15 points.The revive se product was not returned for investigation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.Continued total occlusion is a known potential complication associated with the use of the revive se.The root cause of the event could not be conclusively determined; however, procedural/patient factors may have contributed to the event.Factors that may contributed to failure to remove the clot include thrombus composition (i.E.Calcification), vessel tortuosity at the occluded site and length of the thrombus.Since multiple devices failed to clear the clot, these factors most likely contributed to the failure.Hemorrhage and stroke are known potential complications associated with the revive se.The root cause of the event could not be determined; however, patient and pharmacologic factors may have contributed to the event.The patient had presented with neurological symptoms and the occlusion was not alleviated.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
REVIVE SE 4.5MM OUS
Type of Device
EMBOLECTOMY CATHETER
Manufacturer (Section D)
SEE H10
47709 fremont blvd
freemont CA 94538
MDR Report Key7351314
MDR Text Key102839622
Report Number3008114965-2018-00573
Device Sequence Number1
Product Code DXE
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/28/2019
Device Catalogue NumberFRS21452299
Device Lot NumberT10104
Was Device Available for Evaluation? No
Date Manufacturer Received04/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age94 YR
Patient Weight40
-
-